The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.
Sandoz’s aflibercept biosimilar Enzeevu launch in Canada comes just a few days after the firm signed a multiple asset deal, including an undisclosed ophthalmology product, with Alvotech, which recently gained immediate launch for its Eylea rival in the country.
After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.
Positive results from a randomized study in healthy volunteers mark a key milestone for Alvotech’s proposed Entyvio rivals AVT80 and AVT16.
Strides Pharma aims for higher revenues from Canada and other ex-US markets while waiting for controlled substances to ramp up gradually under the leadership of ex-Apotex CEO Peter Hardwick. However, a cut in US funding for the Global Fund is hurting the company and its competitors.
A biosimilar collaboration between Kashiv and Saya aims to expand access to affordable supportive oncology therapies in Mexico and 10 additional Central America and Caribbean markets.
Amgen has revealed just how significant its first-mover advantage on biosimilar aflibercept has been in the US, with the firm’s Eylea rival bringing in sales of $700m in 2025 and helping to push Amgen’s annual biosimilars turnover up by more than a third to $3bn.
With another settlement secured, US states are gearing up for the first trial of the price-fixing case later this year.
Sun’s founder reinforces the firm’s M&A strategy, indicating that it is "comfortable raising debt" if required, but shares no specific comment on the speculated interest in Organon. The Indian company also has "sufficient supplies" to meet demand for generic semaglutide in India post LoE.
‘These Decisions Created A Lot Of Uncertainty’ – Why The Supreme Court’s Skinny-Label Ruling Matters
The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.
BC Partners has completed its acquisition from Servier of French generics giant Biogaran after the French government allowed the private-equity takeover on condition that BPI France take a minority stake. Meanwhile, former Biogaran CEO Erick Roche has returned to the role after a long stint at Teva.
Just a few days after Alvotech announced global settlements for its Eylea rival, Samsung Bioepis has followed up with its own agreements with the originators.
Teva is lining up Europe as the next regulatory market for its long-acting injectable olanzapine, following its US filing late last year, as the company looks to build a global schizophrenia franchise.
Sandoz and Alvotech have struck a deal that will see the firms collaborate on multiple biosimilar candidates for the Australian, Canadian and New Zealand markets across therapeutic areas including ophthalmology, immunology and gastroenterology.
Transpire Bio continues to advance its complex generics franchise, with another Paragraph IV filing for GSK’s Ellipta portfolio inhaler.
The US Association for Accessible Medicines has named Lupin’s Bob Hoffman as its new chair. Meanwhile, departures have been seen at Stada and Dr Reddy’s, among other industry management changes.
A US class action suit alleges that a settlement between Teva and Novo Nordisk illegally delayed generic Victoza for 16 months, kept prices high and transferred an estimated $903m in value to Teva.
‘It’s A Great Opportunity But It’s Also Late’ – Samsung Bioepis’ Woollett On Biosimilar Streamlining
Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.
Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.
Teva says it has 10 additional biosimilars in development for launch from 2028 onwards, extending its portfolio beyond 2027 as it targets European growth and expands through partnerships.